Aspirin therapy in patients with diabetes without cardiovascular disease resulted in a non-significant 9% relative reduction in the risk of major adverse cardiovascular events (RR 0.91).
Meta-Analysis (n=11,618)
Does aspirin reduce major adverse cardiovascular events in patients with diabetes mellitus without previous cardiovascular disease?
Aspirin for primary prevention in diabetes yields a borderline significant 9% relative reduction in MACE, with an absolute risk reduction of 1.09% and a trend toward increased bleeding, suggesting the need for individualized risk-benefit assessment.
Effect estimate: RR 0.91 (95% CI 0.82-1.00)
Absolute Event Rate: 11% vs 12.1%
BACKGROUND: Aspirin has been recommended for the prevention of major adverse cardiovascular events (MACE, composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) in diabetic patients without previous cardiovascular disease. However, recent meta-analyses have prompted re-evaluation of this practice. The study objective was to evaluate the relative and absolute benefits and harms of aspirin for the prevention of incident MACE in patients with diabetes. METHODS: We performed a systematic review and meta-analysis on seven studies (N=11,618) reporting on the use of aspirin for the primary prevention of MACE in patients with diabetes. Two reviewers conducted a systematic search of electronic databases (MEDLINE, EMBASE, the Cochrane Library, and BIOSIS) and hand searched bibliographies and clinical trial registries. Reviewers extracted data in duplicate, evaluated the quality of the trials, and calculated pooled estimates. RESULTS: A total of 11,618 participants were included in the analysis. The overall risk ratio (RR) for MACE was 0.91 (95% confidence intervals, CI, 0.82-1.00) with little heterogeneity among trials (I2 0.0%). Secondary outcomes of interest included myocardial infarction (RR, 0.85; 95% CI, 0.66-1.10), stroke (RR, 0.84; 95% CI, 0.64-1.11), cardiovascular death (RR, 0.95; 95% CI, 0.71-1.27), and all-cause mortality (RR, 0.95; 95% CI, 0.85-1.06). There were higher rates of hemorrhagic and gastrointestinal events. In absolute terms, these relative risks indicate that for every 10,000 diabetic patients treated with aspirin, 109 MACE may be prevented at the expense of 19 major bleeding events (with the caveat that the relative risk for the latter is not statistically significant). CONCLUSIONS: The studies reviewed suggest that aspirin reduces the risk of MACE in patients with diabetes without cardiovascular disease, while also causing a trend toward higher rates of bleeding and gastrointestinal complications. These findings and our absolute benefit and risk calculations suggest that those with diabetes but without cardiovascular disease lie somewhere between primary and secondary prevention patients on the spectrum of benefit and risk. This underscores the importance of considering individual risk in clinical decision making regarding aspirin in those with diabetes.
Butalia et al. (Sat,) conducted a meta-analysis in Diabetes mellitus without previous cardiovascular disease (n=11,618). Aspirin vs. Cardiac-neutral comparator (placebo or vitamins) was evaluated on Major adverse cardiovascular events (MACE: composite of non-fatal myocardial infarction, non-fatal ischemic stroke, and cardiovascular death) (RR 0.91, 95% CI 0.82-1.00). Aspirin therapy in patients with diabetes without cardiovascular disease resulted in a non-significant 9% relative reduction in the risk of major adverse cardiovascular events (RR 0.91).